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$Bacterial therapy shows early clinical efficacy in patients with treatment-refractory solid tumors$

Bacterial therapy shows early clinical efficacy in patients with treatment-refractory solid tumors

A phase I clinical trial investigating the use of bacterial Clostridium novyi-NT spores as an injectable monotherapy had manageable toxicities and showed early clinical efficacy in patients with treatment-refractory solid tumor malignancies, according to data presented at the Fourth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival, held Sept. 30-Oct. 3.

30 Sep 2018

Promising vaccine may provide new treatment option for patients with HER2-positive cancers

Treatment with a HER2-targeted therapeutic cancer vaccine provided clinical benefit to several patients with metastatic HER2-positive cancers who had not previously been treated with a HER2-targeted therapeutic, according to data from a phase I clinical trial presented at the Fourth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival, held Sept. 30-Oct. 3.

30 Sep 2018

New combination therapy shows potential in treating incurable HPV-related cancers

A tumor-specific vaccine combined with an immune checkpoint inhibitor shrank tumors in one third of patients with incurable cancer related to the human papilloma virus (HPV) in a phase II clinical trial led by investigators at The University of Texas MD Anderson Cancer Center and reported in JAMA Oncology.

28 Sep 2018

Non-small cell lung cancer patients survive longer when treated with durvalumab

Non-small cell lung cancer patients survive longer when their treatment includes durvalumab following platinum-based chemoradiotherapy, according to research led by Moffitt Cancer Center.

27 Sep 2018

Cidara initiates Phase 3 clinical trial to evaluate efficacy, safety of rezafungin to treat invasive candidiasis

Cidara Therapeutics, Inc., a biotechnology company developing novel anti-infectives including immunotherapies, today announced that the first trial site has been activated for ReSTORE, a Phase 3 clinical trial evaluating the efficacy and safety of the company's lead antifungal, rezafungin, to treat candidemia and invasive candidiasis.

27 Sep 2018

FLX Bio treats first patient in its Phase 1/2 clinical trial of FLX475 for treating various advanced cancers

FLX Bio, Inc., a clinical-stage, biopharmaceutical company focused on the development of oral small-molecule drugs that target drivers of cancer and other immune-related disorders, today announced that the first patient has been treated in its Phase 1/2 clinical trial of FLX475 in patients with various advanced cancers. FLX475 is an oral, small molecule CCR4 antagonist that selectively inhibits migration of regulatory T cells into the tumor microenvironment.

27 Sep 2018

CytoSen receives favorable response from FDA to its pre-IND meeting package for CSTD002-NK

CytoSen Therapeutics, a private biopharmaceutical company accelerating innovation in Natural Killer cell therapy, today announced it has received a favorable response from the U.S. Food and Drug Administration to its pre-Investigational New Drug meeting package for the proposed Phase 2 trial of CytoSen's adoptive NK cell therapy, CSTD002-NK, for the reduction of relapse in high risk acute myeloid leukemia or myelodysplastic syndrome in patients undergoing haploidentical hematopoietic stem cell transplantation.

27 Sep 2018

Alnylam announces positive results from Phase 3 Study of givosiran for treating acute hepatic porphyria

Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced today positive topline results from the interim analysis of the ENVISION Phase 3 Study of givosiran, an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 for the treatment of acute hepatic porphyria.

27 Sep 2018

Decibel obtains exclusive license to commercialize ORC-13661 for preventing hearing, balance disorders

Decibel Therapeutics and Oricula Therapeutics today announced that Decibel has obtained an exclusive, worldwide license to the development and commercialization of ORC-13661, an oral medication developed by Oricula Therapeutics for the prevention of hearing loss and balance disorders that can occur following treatment of severe infections with aminoglycoside antibiotics.

27 Sep 2018

Brigatinib drug may offer first-line treatment option for ALK-positive NSCLC

Results of a 275-patient, multi-national phase III clinical trial known as ALTA-1L published today in the New England Journal of Medicine and presented concurrently in the press program at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer 2018 argue for brigatinib as a first-line treatment option for advanced ALK-positive non-small cell lung cancer.

26 Sep 2018

New TB vaccine effective in half of the population in phase II trials

GlaxoSmithKline has come up with an experimental vaccine against tuberculosis (TB) that has shown effective prevention of the infection in half of the population it has been administered to. This could be a breakthrough in preventing the killer disease say researchers since most of the recent vaccines developed against the disease have failed to show efficacy.

26 Sep 2018

Cerevance starts dosing in Phase I clinical trial of CVN424 for treatment of Parkinson's disease

Cerevance, a clinical-stage drug discovery and development company focused on brain diseases, today announced the start of dosing in a Phase I first-in-human clinical trial of CVN424, an oral compound being developed for symptomatic treatment of Parkinson's disease.

25 Sep 2018

Phase 1 and 2 clinical trials of entrectinib drug in ROS1-positive NSCLC show promising results

Results of phase 1 and phase 2 clinical trials of the drug entrectinib in ROS1-positive non-small cell lung cancer presented on the press program of the International Association for the Study of Lung Cancer 19th World Conference on Lung Cancer show a response rate of 77.4 percent for 53 patients evaluable for response, with median duration of response of 24.6 months.

25 Sep 2018

Clinical trial investigators found non-compliant with requirement to report results on EU register

According to EU legislation, clinical trials must be prospectively registered in the European Union Clinical Trials Register and the main results must be reported there one year after completion of the trial. This information is thus publicly available.

25 Sep 2018

Lumos acquires license for LUM-201 drug that promotes secretion of growth hormone

Lumos Pharma, Inc., a clinical stage biopharmaceutical company focused on development and commercialization of therapeutics for rare and neglected diseases, today announced that it has acquired the license for LUM-201, an investigational orally administered small molecule that promotes secretion of growth hormone from the pituitary gland, from Ammonett Pharma LLC.

24 Sep 2018

Alexion announces positive results from Phase 3 PREVENT study of Soliris in patients with NMOSD

Alexion Pharmaceuticals, Inc. today announced positive topline results from the Phase 3 PREVENT study of Soliris in patients with anti-aquaporin-4 auto antibody-positive neuromyelitis optica spectrum disorder.

24 Sep 2018

FDA lifts partial clinical hold that paused enrollment of new patients in tazemetosta clinical trials

Epizyme, Inc., a clinical-stage company developing novel epigenetic therapies, today announced the U.S. Food and Drug Administration has lifted the partial clinical hold that had paused U.S.-based enrollment of new patients in its tazemetostat clinical trials.

24 Sep 2018

FARXIGA receives positive results in Phase III DECLARE-TIMI 58 cardiovascular outcomes trial

AstraZeneca today announced positive results from the Phase III DECLARE-TIMI 58 cardiovascular outcomes trial for FARXIGA, the broadest SGLT-2 inhibitor CVOT conducted to date.

24 Sep 2018

Biogen and Eisai announce results of LTE Phase 1b study of aducanumab for treating MCI

Biogen and Eisai Co., Ltd. announced results from a recent analysis of the ongoing long-term extension Phase 1b study of aducanumab, an investigational treatment for mild cognitive impairment due to Alzheimer's disease and mild AD dementia.

24 Sep 2018

CHMP recommends approval of Gilenya for treatment of multiple sclerosis in children, adolescents

Novartis today announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Gilenya (fingolimod) for the treatment of children and adolescents 10 to 17 years of age with relapsing remitting forms of multiple sclerosis.

24 Sep 2018

Drug Trial News

Bacterial therapy shows early clinical efficacy in patients with treatment-refractory solid tumors

Promising vaccine may provide new treatment option for patients with HER2-positive cancers

New combination therapy shows potential in treating incurable HPV-related cancers

Non-small cell lung cancer patients survive longer when treated with durvalumab

Cidara initiates Phase 3 clinical trial to evaluate efficacy, safety of rezafungin to treat invasive candidiasis

FLX Bio treats first patient in its Phase 1/2 clinical trial of FLX475 for treating various advanced cancers

CytoSen receives favorable response from FDA to its pre-IND meeting package for CSTD002-NK

Alnylam announces positive results from Phase 3 Study of givosiran for treating acute hepatic porphyria

Decibel obtains exclusive license to commercialize ORC-13661 for preventing hearing, balance disorders

Brigatinib drug may offer first-line treatment option for ALK-positive NSCLC

New TB vaccine effective in half of the population in phase II trials

Cerevance starts dosing in Phase I clinical trial of CVN424 for treatment of Parkinson's disease

Phase 1 and 2 clinical trials of entrectinib drug in ROS1-positive NSCLC show promising results

Clinical trial investigators found non-compliant with requirement to report results on EU register

Lumos acquires license for LUM-201 drug that promotes secretion of growth hormone

Alexion announces positive results from Phase 3 PREVENT study of Soliris in patients with NMOSD

FDA lifts partial clinical hold that paused enrollment of new patients in tazemetosta clinical trials

FARXIGA receives positive results in Phase III DECLARE-TIMI 58 cardiovascular outcomes trial

Biogen and Eisai announce results of LTE Phase 1b study of aducanumab for treating MCI

CHMP recommends approval of Gilenya for treatment of multiple sclerosis in children, adolescents

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